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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATEX-OHMEDA, INC. AISYS; ANESTHESIA GAS MACHINE

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DATEX-OHMEDA, INC. AISYS; ANESTHESIA GAS MACHINE Back to Search Results
Device Problem Infusion or Flow Problem (2964)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/30/2021
Event Type  malfunction  
Manufacturer Narrative
Date of device manufacture year is 2007.The month of manufacture was unavailable at time of mdr filing.Patient information could not be obtained due to country privacy laws.The initial reporter is located outside the u.S., and therefore this information is not provided due to country privacy laws.A ge healthcare service representative performed a checkout of the system and confirmed the reported issue.The bag to vent switch was replaced to resolve the reported issue.
 
Event Description
The hospital reported a malfunction resulting in the loss of manual ventilation.There was no report of patient injury.
 
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Brand Name
AISYS
Type of Device
ANESTHESIA GAS MACHINE
Manufacturer (Section D)
DATEX-OHMEDA, INC.
3030 ohmeda dr,
madison, WI 53718
Manufacturer (Section G)
DATEX-OHMEDA, INC.
3030 ohmeda dr,
madison, WI 53718
Manufacturer Contact
john szalinski
MDR Report Key12241690
MDR Text Key264083663
Report Number2112667-2021-01787
Device Sequence Number1
Product Code BSZ
Combination Product (y/n)N
PMA/PMN Number
K172045
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Type of Report Initial
Report Date 07/28/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/28/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received06/30/2021
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
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